requirement that all
parties must put in writing their respective responsibilities in
assuring the protection of human subjects when an assuring institution (NPC)
is engaged in cooperative research with other organizations (VAMC and
University) and relies on another organization’s (University)
IRB.
Consistent with the authority provided in 45 CFR
§46.114 and 38 CFR §16.114, the NPC established under 38 USC
§§7361-7368, VAMC and University wish to avoid duplication
of effort in the oversight of cooperatively conducted human studies
research. Recognizing that NPC research is VA-approved research
subject to policies and procedures contained in VA manuals, regulations
and statutes, NPC, VAMC and University agree that
all oversight for such studies will be provided by VAMC and the
University IRB consistent with:
1) University IRB operating policies and
procedures (insert reference to documentation appropriate for
University IRB); and
2) Existing or subsequent VAMC - University
agreements assigning respective responsibilities.
Subject to 1) and 2) above, such VAMC and
University oversight will include:
- Monitoring review and approval of projects and
related documentation to ensure compliance with human subject
protection requirements
- Monitoring the performance of studies to ensure
compliance with human subject protection requirements
- Providing investigators and other relevant
personnel with mandatory training and monitoring compliance with
training requirements
The only exception is that the NPC
Federalwide Assurance (FWA) signatory official must complete the
required initial and continuing training and is responsible for ensuring
that relevant NPC employees also do so.
NPC relies on VA
handbooks, regulations and statutes as well as local VAMC, R&D
Committee, University and IRB policies and procedures regarding
communication among relevant parties and sharing of documentation.
Signatories (as appropriate for local
circumstances):
